- 6 mo1,433 devices1.1×
- 1 yr1,098 devices1.5×
- 2 yr863 devices1.9×
- 3 yr637 devices2.5×
Biology & Medicine
Protein structure, drug discovery, lab science and biosecurity evaluations.
Progress over time
Charts
AI-enabled medical devices authorised in the US
Running total of devices on the FDA's own list of AI-enabled medical devices, by the year the agency made its final decision.
What this measures: A medical device can only be sold in the United States after the FDA clears or approves it. The agency publishes a list of the ones that use artificial intelligence. Most are software that reads medical scans, not chatbots.
05001,0001,5002,000201120132015201720192021202320252027
The last point covers only the first half of 2026. The FDA's list ran to decisions made up to 29 June 2026 when it was last updated on 4 September 2026, so the 2026 total will rise.
Counted from the FDA's CSV of the list (file dated 4 September 2026): 1,614 authorisations. 1,553 used the 510(k) route, which asks whether a device matches one already on the market, and 1,230 are radiology devices. Some products appear more than once as later versions were authorised (1,317 distinct device names from 817 companies). The FDA says the list is not comprehensive.
Sources: US Food and Drug Administration, JAMA Network Open via PubMedData as of 9 Nov 2026
Show data table and sources
| Date | Label | Value |
|---|---|---|
| 31 Dec 2010 | 18 devices | |
| 31 Dec 2013 | 30 devices | |
| 31 Dec 2015 | 42 devices | |
| 31 Dec 2016 | 60 devices | |
| 31 Dec 2017 | 87 devices | |
| 31 Dec 2018 | 152 devices | |
| 31 Dec 2019 | 232 devices | |
| 31 Dec 2020 | 346 devices | |
| 31 Dec 2021 | 475 devices | |
| 31 Dec 2022 | 637 devices | |
| 31 Dec 2023 | 863 devices | |
| 31 Dec 2024 | 1,098 devices | |
| 31 Dec 2025 | 1,433 devices | |
| 29 Jun 2026 | 1,614 devices | 1,614 devices |
- List of Artificial Intelligence-Enabled Medical Devices (US Food and Drug Administration)
- AI-enabled medical devices list (CSV download) (US Food and Drug Administration)
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices (JAMA Network Open via PubMed)
Entries
Notable
Anthropic's first drug results with Claude: six partners, one 25-hour review cut to 3 hours
Anthropic says Claude helped redesign a cancer therapy and drew up 35,000 antibody designs in a month. Almost none is tested in people yet.
6drug developers in Anthropic's first results, nearly all preclinical
Finding1 source
Myth check: “AI can't create new knowledge, it only remixes its training data”
Verdict: FalseAI disproved an 80-year-old conjecture and designed antibiotics that worked in mice. Real finds come where answers can be checked.
Myth check7 sources
Notable
An AI-discovered drug for a lung disease entered final-stage trials; none is approved yet
In a 71-patient trial, lung capacity rose on the drug and fell on placebo over 12 weeks. A 320-patient final trial began in September 2026.
+98.4 mL vs −20.3 mL12-week change in lung capacity, top dose vs placebo (71 patients)
Milestone5 sources
US regulators have cleared 1,614 medical devices that use AI, most of them to read scans
The FDA's list counts 1,614 AI devices since 1995, 335 of them in 2025 alone. In one study of 903 such devices, 4.8% were later recalled.
1,614AI devices on the FDA's list, 1995 to 29 June 2026
Milestone3 sources
AI designed 16 working viruses that attack bacteria
AI designed whole genomes for viruses that infect only bacteria; 16 of hundreds built worked. Such viruses may stand in for antibiotics.
16AI-designed viruses that worked (Science, August 2026)
Milestone4 sources
AI breast screening found more cancers and cut radiologists' reading work by 44%
In Sweden's MASAI trial, AI-supported screening caught 80.5% of cancers, against 73.8% for two radiologists, with no rise in false alarms.
80.5% vs 73.8%cancers found at screening: AI help vs two radiologists alone
Finding5 sources
DeepMind's AlphaGenome predicts what a single change in DNA does to gene activity
AlphaGenome reads up to a million DNA letters at once. DeepMind reports it matched or beat other models on 24 of 26 tests.
24 of 26tests where it matched or beat other models, as DeepMind reports
Milestone2 sources
An asthma drug its maker says AI designed is in two final-stage trials of 786 patients each
Trials of a twice-yearly asthma injection began in late 2025 and early 2026. Results are due in 2028 and 2029; nothing is approved yet.
786 + 786patients planned in the two final-stage trials (registry, Nov 2026)
Milestone4 sources
AI designed antibodies from scratch and 4 of 5 came out the exact shape predicted
A University of Washington lab had AI design antibodies for a chosen spot on a target. Shapes matched, but they grip too weakly for drugs.
4 of 5AI-designed antibodies whose real shape matched the prediction
Milestone5 sources
A Google AI reached in days an explanation a London lab had spent years proving
Asked how certain bacterial genes spread, Google's AI proposed the answer an Imperial College team had proved but not yet published.
Days vs yearsAI's time to the idea, against the lab's years of experiments
Finding4 sources
AI invented new antibiotics from scratch: 7 of 24 killed bacteria, 2 worked in mice
MIT researchers had AI design new antibiotic molecules. Two cleared drug-resistant infections in mice; none has been tried in people yet.
7 of 24AI-designed molecules that could be made and that killed bacteria
Milestone3 sources
Doctors who got used to AI in colonoscopies spotted fewer growths without it, in one study
Detection without AI fell from 28.4% to 22.4% at four Polish clinics after the tool arrived. A bigger later trial found no such drop.
28.4% to 22.4%growths found without AI, before vs after the tool arrived
Finding2 sources
AI designed a new gene editor that edits human DNA, and it is free to use
An AI trained on over a million natural CRISPR systems invented it. It works on human DNA in the lab and is free to use, even commercially.
about 400 mutationshow far the AI's editor sits from the standard natural one
Milestone2 sources
AI-designed proteins saved mice from a deadly snake toxin, given 15 minutes afterwards
Snakebite antidotes are still made from horse and sheep blood. Computer-designed proteins saved all five mice given one after a lethal dose.
5 of 5 mice survivedgiven the designed protein 15 minutes after a lethal toxin dose
Milestone2 sources
AlphaFold won half a Nobel for predicting protein shapes; its free database holds 261 million
Two Google DeepMind researchers shared the 2024 chemistry Nobel for AlphaFold, which predicts how proteins fold. Its results are free.
260,986,406predicted protein shapes anyone can look up free (Nov 2026)
Milestone7 sources